Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 98/04/99; HTA 98/04/64

Study information

Scientific title

Acronym

ARTISTIC

Study hypothesis

1. To study a randomised population of women undergoing cytological screening in whom an HPV test result is revealed with a smaller cohort in whom the result is concealed. 2. To study the psychological and psychosexual differences between corresponding cytological groups in the two study arms. 3. To study the economic benefits or otherwise of HPV testing. 4. To study the predictive ability of HPV testing positive or negative in the presence of normal cytology in terms of future risk, and screening intervals. 5. To see if HPV testing achieves a more efficient protocol following "inadequate" smears and low grade smears. 6. To evaluate the relevance of viral persistence and load in predicting risk. 7. To evaluate sensitivity, specificity and negative predictive value of HPV testing. 8. To compare the results of different HPV testing methods in terms of objective 7 and also to examine interlaboratory variation.

Updated 14/01/2008: the anticipated start and end dates of this trial were updated from 01/04/2000 and 31/03/2006 to 01/06/2001 and 30/11/2009, respectively.

Updated 30/09/2013: the NIHR has awarded funding to extend the follow-up of this trial until 2015. This will be done by linkage with national screening and cancer registration records without recontacting patients.

Ethics approval

North West Multi-centre Research Ethics Committee, approved on 18/08/2000 (ref: MREC 00/8/30)

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Condition

Cervical cancer

Intervention

Women who are attending for cervical screening, all of whom will have a smear and an HPV test, will be individually randomised in a ratio of 3:1 to a study arm (HPV test revealed) and a control arm (HPV test concealed). The control arm will be managed by routine clinical practice as per national guidelines with a rescreen and HPV test at 3 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

1. Reduction of high and low grade smears in the HPV revealed arm, at the next screening round2. The difference in psychological and psychosexual outcomes in the HPV revealed arm as a consequence of knowledge of the HPV test result3. Cost: the number of women experiencing the cost generating events (cytology, HPV test, colposcopy, biopsy and treatment and ad hoc primary care consultations) will be identified and the associated unit costs will be estimated and attached to these events to determine total costs in each arm. Cost effectiveness will be presented as an incremental cost per additional high grade smear detected, and as an incremental cost per life year gained and per quality adjusted life year gained (estimated by extrapolating from the trial endpoint using modelling techniques).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

01/01/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women aged 20-64 weighted by age bands to achieve a spread of HPV positives across the age range.